WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer

WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence

This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6 cycles.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Carcinoma
• Intervention / Treatment: Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin; Other: Isotonic saline (perfusate); Procedure: Surgery; Drug: Carboplatin; Drug: Paclitaxel

Detailed Description

OBJECTIVES

• The primary objectives are

  • to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fallopian tube, or primary peritoneal carcinoma
  • to determine the feasibility of delivering HIPC in a recurrent setting.

• Secondary objectives are

  • to determine disease free survival (DFS) and overall survival (OS),
  • to determine treatment related changes in quality of life (QOL)
  • to monitor the toxicities and complications associated with HIPC.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients should have a histological diagnosis of primary ovarian, fallopian tube, or primary peritoneal carcinoma and have undergone chemotherapy according.
• Initial attempted cytoreductive surgery must have been performed by gynecologic oncologist with strict adherence to GOG surgical manual.
• End result of first surgery must have been optimal cytoreduction as defined as no residual tumor ≥ 1cm.
• Patients should have clinical evidence of first recurrence. Two fold elevations in CA125 or measurable tumor on CT scan constitute adequate evidence of recurrent disease.
• Patients with the following primary tumor epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma (non-specific) NOS, mixed epithelial carcinoma.
• Patients must have platin sensitive disease, defined as a recurrence occurring greater than 6 months from cessation of original treatment.
• Patients must have a performance status of 0, 1, 2.
• Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) ≥1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
• Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
• Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
• Patients who have signed an Institutional Review Board (IRB) approved informed consent.
• Female patients 16-90 years of age.
• Patients must be deemed medically able to undergo a secondary surgical procedure.

Patient eligibility for systemic chemotherapy following HIPC:

• Patients must have successfully completed HIPC within 6 weeks of first prescribed intravenous carboplatin and taxane cycle.
• Patients must have a performance status of 0, 1, or 2.
• Patients must have adequate bone marrow function as defined as an ANC ≥ 1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
• Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
• Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
• Patients who have signed an IRB approved informed consent.

Exclusion Criteria:

• Patients with known recurrent disease outside the abdominal cavity.
• Patients with low malignant tumor at primary diagnosis as determined by pathologic review.
• Patients with platin resistant disease as define as recurrence or progressive disease prior to 6 months from completion of primary therapy.
• Patients with any evidence of another malignancy within the last 5 years with the exception of non-melanoma skin cancer.
• Patients with evidence of concurrent septicemia, severe infection, renal failure, or acute hepatitis.
• Patients with history of grade 3 or greater gastrointestinal bleeding.
• Patients with a GOG performance score of 3 or 4.
• Patients deemed medically unable to tolerate the HIPC procedure by care giving physician.
• Patients with known allergy to platinum chemotherapy agents.
• Patients with equal to or greater than grade 2 neuropathy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: HIPC Treatment

Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin; Carboplatin at a dose of 1000mg/m^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes.; Other: Isotonic saline (perfusate); The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.; Other Names: saline; Procedure: Surgery; The abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus. If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach.; Drug: Carboplatin; The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.; Drug: Paclitaxel; The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.; Other Names: Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response	We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.	After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)
Feasibility of HIPC in Recurrent Disease Setting	We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Measurements	The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.	Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27
Progression-free Survival	Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).	Up to 5 Years (intended)
Overall Survival	Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.	Up to 5 Years

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Peter Argenta, MD, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2010
• Primary Completion (ACTUAL): September 25, 2013
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (ESTIMATE): June 15, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: recurrent ovarian cancer; recurrent fallopian tube cancer; recurrent peritoneal carcinoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Disease Attributes; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Recurrence; Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: 2009LS114; WCC# 59 (OTHER: Women's Cancer Center, University of Minnesota); 1003M78874 (OTHER: IRB, University of Minnesota)